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Serious recall: Injury is possible or has been reported. Take action promptly.

Mckesson Medical-Surgical Inc. Corporate Office 2025-07-30 Health serious FDA
Health · FDA · Recall #FDA-D-0539-2025

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx… Recall

Issued July 30, 2025 · Mckesson Medical-Surgical Inc. Corporate Office

In July 2025, Mckesson Medical-Surgical Inc. Corporate Office recalled the EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

CGMP Deviations; potential temperature excursions due to transit delays

What you should do

  1. 1 Stop using EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Mckesson Medical-Surgical Inc. Corporate Office to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Mckesson Medical-Surgical Inc. Corporate Office
Category
Health
Recall date
July 30, 2025
Units affected
Not reported
Sold at
Within the U.S - OH, VA, FL.
Recall number
FDA-D-0539-2025
Made in
United States
Issuing agency
FDA

In context

Read the official FDA notice

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